Actively Recruiting

Age: 13Years - 30Years
FEMALE
Healthy Volunteers
NCT06124599

Prodromes of Menstrual Staphylococcal Toxic Shock

Led by Hospices Civils de Lyon · Updated on 2024-12-06

316

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Menstrual staphylococcal toxic shock is a rare but severe disease, requiring intensive care in over 80% of cases. Menstrual staphylococcal toxic shock develops during the peri-menstrual period, in healthy young women colonized by a vaginal strain of Staphylococcus aureus secreting the Toxic shock syndrome toxin 1 (TSST-1) and not immune to it, in a favorable environment, i.e. wearing intravaginal menstrual protection (tampon, menstrual cup). The rarity of the syndrome, its polymorphous clinical presentation and the absence of a totally specific biological examination make menstrual staphylococcal toxic shock a difficult pathology to diagnose. The reference clinical criteria correspond to the advanced picture of multivisceral failure, making it possible to classify cases a posteriori, but contribute to diagnostic delay and lack sensitivity. Patient accounts suggest the presence of symptoms in the days preceding the development of toxic shock, and also during previous menstrual cycles. The identification of prodromal symptoms could enable earlier management of menstrual staphylococcal toxic shock by removal of intra-vaginal sanitary protection, the main risk factor, before the disease becomes permanently established and requires intensive care.

CONDITIONS

Official Title

Prodromes of Menstrual Staphylococcal Toxic Shock

Who Can Participate

Age: 13Years - 30Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women between 13 and 30 years old inclusive
  • Clinical diagnosis of staphylococcal toxic shock syndrome: confirmed or probable according to CDC criteria
  • Detection of S. aureus strain carrying Toxic shock syndrome toxin-1 (TSST1) on vaginal samples
  • Onset of symptoms within 72 hours before to 72 hours after menstruation
  • Use of tampons or menstrual cups during the last 3 menstrual cycles
  • For controls: women between 13 and 30 years old inclusive
  • For controls: presence of menstruation
  • For controls: use of tampons or menstrual cups during the last 3 periods
  • For controls: no history of toxic menstrual shock
Not Eligible

You will not qualify if you...

  • Non-menstruating women
  • Women protected by law
  • Women or relatives who oppose the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hopital Nord Croix Rousse

Lyon, France, 69004

Actively Recruiting

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Research Team

G

Gerard LINA, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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